Tag: EFSA

Near-complete ban on the use of neonicotinoid insecticides across the EU

Government representatives approved on Friday a European Commission proposal to impose a near-total ban on three neonicotinoid pesticides that have been linked to drastic falls in populations of bees

Brussels, 27th April – Today, Member States have backed the proposal from the European Commission to ban all outdoor uses of 3 bee-killing neonicotinoids. By the end of the year, imidacloprid, clothianidin and thiamethoxam insecticides will finally disappear from our environment for the sake of our bees. PAN Europe warmly welcomes the European Commission’s steadiness in resisting to several Member States and the agroindustry that favour unsustainable practices in conventional farming.

A quarter of a century after being approved, neonicotinoids will be banned within a few months. EU Member States were requested to vote today on the proposal from the European Commission to ban all outdoor uses of 3 bee-killing neonicotinoids.

Since their approval at EU-level in the 90’s, neonicotinoids have been largely proven to harm honey bees, other pollinators and the environment as a whole. Several studies also indicate toxicity on human health.

After years of battle from beekeepers and environmentalists, the European Commission restricted the use of 3 highly bee-toxic neonicotinoids in 2013. Imidacloprid, clothianidin and thiamethoxam were then banned on bee-attractive crops.

Since then, evidence showed that even application of neonicotinoids on non-bee-attractive crops led to exposure of bees as these substances are highly persistent in the environment. In the meantime, the European Food Safety Authority (EFSA) published a series of reports highlighting that there is no safe use for bees for these 3 insecticides. Based on EFSA’s conclusions, DG Sante sent to the Member States a proposal to ban all outdoor uses for these 3 substances in March 2017. Another EFSA report from February 2018 has permitted DG Sante to speed up the process and to ask Member States to vote on its proposal today.

Martin Dermine, PAN Europe’s Health and Environment Policy Officer said:

‘Authorising neonicotinoids during a quarter of a century was a mistake and led to an environmental disaster. Today’s vote is historic. A majority of Member States gave a clear signal that our agriculture needs transition. Using bee-killing pesticides cannot be allowed anymore and only sustainable practices should be used to produce our food’.

PAN Europe is a member of the Save the Bees Coalition, a coalition gathering more than 100 EU NGOs that acted at EU and national levels to obtain today’s ban.  Reference.

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Pesticide risk assessment regulatory use designed and/or promoted by the industry

The chemical industry writes its own rules

Summary

Research done by the Pesticide Action Network reveals that in 92% (11 out of 12) of the EU-methods for pesticide risk assessment examined, it was the industry that designed and/or promoted their regulatory use. Industry is writing its own rules. This is a major conflict of interest. The cases concern criteria and methods (risk assessment methodologies) on HOW the rules of the pesticide Regulation 1107/2009 should be used in decision-taking on individual pesticides. In most cases European Food Safety Authority, EFSA, drafted the guidelines on the use of these criteria and methods. Such methods are used to dismiss tumours observed in animal toxicity testing of pesticides, to approve carcinogenic pesticides in our food, to classify polluting pesticide metabolites in our groundwater as irrelevant, to allow the dying of 50% of the insects in every spraying turn, to construct ‘safe’ levels for harmful pesticides without any experimental evidence, among others.

Industry, spearheaded by industry lobby group ILSI (International Life Sciences Institute), developed their desired methods during the past 15 years in a series of invited-only meetings with industry employees and a few university professors that generally shared their views. Next it tried to get its allies in regulatory expert panels that draft opinions on the methods like the panels of EFSA, IPCS/WHO (World Health Organisation/ International Program on Chemical Safety), JMPR (WHO Joint Meeting on Pesticide Residues) and other agencies.

In 75% (9 out of the 12) of the risk assessment methods studied by the Pesticide Action Network, industry-linked experts managed to get
a seat in EU and global panels where these methods were produced. Generally there were only a handful of experts present in the panels that decided on far-reaching opinions about the methods. Only rarely were experts present in these meetings that are actively conducting experimental scientific work. In any case, not much science is used for drafting opinions on risk assessment methods in panels. “Expert judgement” is the prevailing practice, which is in fact just the opinions and ‘feelings’ of those that are present in the room. The global scientific societies that bundle the hundreds of thousands of scientists that do scientific research in the world are not involved nor asked to do a peer-review of these methods of risk assessment, which is the standard procedure for scientific work. In none, 0% (0 out of 12) of the methods studied by the Pesticide Action Network, the method was peer-reviewed by independent academic scientists.

Since a solid conflict-of-interest policy was lacking in the beginning of this century in most agencies, many expert panels have been dominated by experts that support the views of industry. In the case of TTC (Threshold of Toxicological Concern; a method to design safe levels for pesticides) up to 77% (10 out of the 13) of the experts in the EFSA-working group were linked to industry and were promoting this method in the past.

Food Authority EFSA is known for having close ties to industry. In 50% (6 out of the 12) of the methods studied by the Pesticide Action Network, EFSA and other agencies had exclusive meetings with industry on the design of the methods, sidelining other stakeholders.

Industry obtained most of its inspiration from the US where citizens are not protected by the precautionary principle and the burden of proof on harmfull effects of pesticides is put largely on the public. An entirely different system therefore from the EU system. Yet, in 67% (8 out of the 12) of the methods studied by the Pesticide Action Network, an US-origin could be seen. Without a doubt the US-type of risk assessment is invading the EU-system through the backdoor.

The 12 methods studied here all are designed to lower the level of protection of the public and to enable the approval of pesticide that can cause harm. On top of this, the methods adopted are even misused in practice. In 92% (11 out of 12) of the methods studied by the Pesticide Action Network misuse was observed in actual decision-making of EU pesticide approval.

A full revision of the EU risk assessment methods is needed, according to the Pesticide Action Network. Fully independent scientists that are actively conducting experimental work as a daily practice should be tasked to do this to protect the public with the newest scientific in sights and knowledge.

Continue reading Industry writing Its own rules, a research report written by the Pesticide Action Network Europe, January 2018.

‘Emerging risks’ identified as first of four key stages in a risk cycle

Assigning risk ownership is not always simple, especially where the risk sits across different areas of responsibility

Risk governance tends to be adapted to routine risks, rather than emerging risks, which can evolve rapidly, affecting multiple stakeholders across geo-political boundaries. For example, unforeseen events such as the 2007 financial crisis and 2011 Fukushima disaster have highlighted how the world can quickly change without warning, with no set procedures in place for managing the effects.

Despite this awareness, the literature review found no unified, usable definition of emerging risks that could help policymakers with a framework for managing them. For example, in some definitions, an emergent risk is simply one that a stakeholder has failed to recognise so far, therefore preventing the calculation of probabilities and expected loss. Others emphasise that the risk will have an impact in the next one to five years, making them a priority for action over longer-term risks.

Some organisations highlight the dynamic nature of a risk portfolio, due to new technology, processes, discoveries or behaviours. For example, the European Food and Safety Agency (EFSA) connects emerging risks to newly identified hazards or increased exposure to known hazards. Uncertainty and magnitude of consequences also feature in definitions, yet these can also be associated with risks that are not emerging — thus they are not unique characteristics.

Instead of a type of risk, the study proposes that emerging risks in fact describe a stage in the risk cycle prior to full recognition at the scientific or societal level; at some point, every risk has been ‘emerging’. To deal with the real and socially constructed challenges posed by emerging risks — to mitigate or prevent their consequences — policymakers need to develop capabilities in signal detection and foresight.

The path of risk emergence can go through one or all of three states before reaching full emergence:

  • Ontological
    when combinations of activities and stakes (societal values) with potentially negative outcomes are modified, or when new combinations occur. These risks can be totally hidden from human perception (‘unknown unknowns’) until a change occurs. For example, asbestos has been used for at least 2 000 years, but the first death related to it was only officially recorded in 1906.
  • Epistemological
    when science highlights that an activity poses a threat, although the risk is uncertain and long-term studies are needed to gather evidence of the risk. For example, scientific literature recognises the risk of cancer from exposure to electromagnetic fields, but the extent of this risk is subject to conflicting evidence and only acknowledged by the World Health Organization as a possible carcinogen.
  • Societal
    where a risk is officially recognised, as well as the necessity for dedicated policies, responsibilities and acceptability levels. This stage does not necessarily follow ontological or epistemological emergence, but can be the result of social pressure or the application of the precautionary principle. For example, following the latter, France banned the endocrine disruptor Bisphenol A in 2012, although the EFSA states that exposure levels do not present a health risk.
  • Fully emerged
    where both scientific communities and policymakers agree there is a need to deploy appropriate risk policies, and scientific evidence continues to confirm the need to take action. The researcher argues that public debate on risks in the societal state are not necessarily influenced by scientific knowledge, but ‘fully emerged risks’, e.g. climate change, are confirmed by scientific evidence.

Risk ownership is highlighted at both the epistemological and societal stages. Insurance contracts and court decisions can set precedents with regards to responsibility, even where risks are scientifically controversial. For example, a French court awarded damages to a victim of electro hypersensitivity syndrome in 2015, for the first time. This sends a clear signal that there is a need for regulators and stakeholders to adopt a position on emerging risks even at the scientifically controversial stage. To base governance on scientific evidence, policymakers should make decisions on who holds responsibility for the risks related to novel activities and substances, e.g. nanoparticles, before the debate reaches the societal stage.

This approach invites policymakers to focus on risks at the ontological and epistemological stage in order to manage outcomes. Successfully detecting and interpreting early signals of change can even prevent negative effects of hidden risks. Moreover, the development of foresight capabilities can provide valuable analysis of risks and opportunities that may appear in the future. Both these techniques are fundamental for policymakers when defining the appropriate strategies for managing emerging risks.

Assigning risk ownership is not always simple, especially where the risk sits across different areas of responsibility. With such risks, when no single entity is officially in charge, the risk can be ‘orphaned’, resulting in no action. Governing the risks of global warming and other cross-boundary environmental issues requires going beyond national governance structures. For policymakers, this means long-term planning, co-ordination and collaboration across managerial levels.

Sources and More Information
  • (Re) Defining Emerging Risks, wiley online library, DOI: 10.1111/risa.12759, 2017-03-21.
  • ‘Emerging risks’ identified as first of four key stages in a risk cycle, Science for Environment Policy, Issue 495, 14 September 2017.
  • Featured image credit cerasis.

(Re) Defining Emerging Risks

‘Emerging risks’ identified as first of four key stages in a risk cycle

The phrase ‘emerging risk’ has been widely used in scientific and business communities, but without consensus on how to define and govern such a risk. A new study proposes that risk emergence goes through four states, from ‘unknown unknowns’ to risks that are fully in the public domain. Understanding emergence as a process can help decision makers detect and manage risks on the basis of scientific evidence.

Study Abstract

The concept of emergence in risk management can be seen as a revealing symptom of the increasing need for organizations to update their portfolio of risks and opportunities in a rapidly changing and highly competitive environment. Accordingly, the concept of emerging risks has been widely discussed in both scientific and business communities, with, however, a lack of agreement as to whether we should distinguish these risks from others and, if so, what should be the adopted approach for their governance. After reviewing a large set of definitions and conceptions of emerging risks, this article aims at exploring the existence of distinctive features allowing the characterization of a risk as emerging or not. First, we will demonstrate that the features used in the various definitions are ineffective to achieve this distinction. Furthermore, we will argue that all events and consequences associated with risks are or have been states of nature that emerged from complex interactions involving combinations of hazardous activities and stakes. Accordingly, emerging risks are no longer a specific category of risks; they are rather an early step in every risk life cycle that deserves specific governance approaches.

Sources and More Information
  • (Re) Defining Emerging Risks, wiley online library, DOI: 10.1111/risa.12759, 2017-03-21.
  • ‘Emerging risks’ identified as first of four key stages in a risk cycle, Science for Environment Policy, Issue 495, 14 September 2017.
  • Featured image credit insurancejournal.

Evaluations Applied to Glyphosate Data are Scientifically Flawed and Fail to Protect Public Health

Open Letter from Dr. Christopher Portier, Cancer Expert, on His Review of the Carcinogenicity of Glyphosate European Union Authorities

The President of the European Commission, Jean-Claude Juncker, has received an embarrassing letter last Monday 29 May, 2017.

Christopher Portier, world-renowned toxicologist and biostatistician, former director of several US federal research institutions, has had access to data from confidential studies on glyphosate – those transmitted by industrialists to European authorities. He discovered information that had gone so far unnoticed.

Executive Summary

The European Food Safety Agency IEFSA) and the European Chemical Agency IEChA) have completed their assessments of the carcinogenic potential of glyphosate and concluded that the evidence does not support a classification for glyphosate.

The raw data for the animal cancer studies for glyphosate have been released, and a reanalysis of these data show eight instances where significant increases in tumor response following glyphosate exposure were not included in the assessment by either EFSA or EChA.

This suggests that the evaluations applied to the glyphosate data are scientifically flawed, and any decisions derived from these evaluations will fail to protect public health.

I ask that the evaluations by both EFSA and EChA be repeated for all toxicological endpoints and the data underlying these evaluations be publicly released.

Christopher Portier,
Former Director US National Center for Environmental Health
Former Director US Agency for Toxic Substances and Disease Registry
Former Associate Director, US National Institute of Environmental Health
Sciences
Former Associate Director US National Toxicology Program
Fellow, American Statistical Association
Fellow, International Statistics Institute

Endocrine Disruptors: The Discreet but Major Gift to the Pesticides Lobby

The European Commission submited its proposal for regulation of chemical substances on 21.12.2016

This article by Stéphane Horel was originally published by Le Monde on December 20. This translated version published by EDC-Free Europe.  This work is licensed under a Creative Commons Attribution-ShareAlike 4.0 International License. Image thecvopros.

It’s a paragraph that does not look like anything, added at the bottom of the document at the last minute. In a tortuous and impenetrable formulation, it refers to a derogation for products acting on the “moulting and / or growth of harmful organisms”. But, reformulated in common language, it is no more or less a concession from the European Commission to the pesticide lobby.

A few days before Christmas, Wednesday 21 December, three years late, the Commission is due to submit to a vote its proposed regulation on endocrine disruptors, these ubiquitous chemicals capable of interfering with the hormonal system of living beings at sometimes tiny doses. This proposal is supposed to implement a very strict provision of the European regulation on pesticides: the ban on pesticides that will be recognized as endocrine disruptors.

It is therefore the criteria that allow them to be identified which the Commission has drawn up and which the representatives of the Member States must adopt or reject. The vote will be held in the Standing Committee on the Food Chain and Animal Safety after six months of negotiations.

If the devil is hiding in the details, the paragraph inserted by the Commission at the last minute is anything but anecdotal. While the “pesticides regulation” requires removing endocrine disruptors from the market, the paragraph creates a derogation from identification for a whole group of pesticides that have the particularity of … being endocrine disruptors. Indeed some pesticides wipe out insects or plants known as “pests” to crops by acting on their hormonal system to block their moulting or growth. In other words, these are pesticides that have been designed to be endocrine disruptors. Rather than using this knowledge to identify and prohibit them, the Commission proposes that they be spared.

Request from the trio BASF, Bayer and Syngenta

This major derogation is in fact an old request of the pesticide industry. It was developed by the trio of pesticide manufacturers who will be most affected by the regulation: the German giant BASF (the world leader in chemistry) and Bayer (being merged with Monsanto) and the Swiss group Syngenta. In a document dated 2013, employees of these groups argue for a “derogation” for what they refer to as “endocrine disruptors by design”:

“Strictly speaking, such compounds would fulfil the endocrine disruptor definition as their endocrine mechanism and adverse population-relevant effects are intended and well-described.  (…) Consequently, an exemption category for these chemicals should be defined.. ”

The new paragraph resembles in an unmistakable way the article written by employees of pesticide manufacturers.

But the exemption is problematic for living beings, which could be affected by these endocrine disrupting pesticides, from plants to ladybugs, passing by nearby squirrels,  that is all those that the law calls “non-target organisms” but are also equipped with a hormonal system liable to be hijacked by these products.

Weed killer classified as “possible human carcinogen”

While there is no assessment of the consequences of this clause on the ecosystem, it will undoubtedly have a positive impact on the industry. According to information gathered by Le Monde, this exception would correspond to about 15 insecticides and a handful of herbicides including 2,4-D, a herbicide that has also been classified as a “possible human carcinogen” by the International Agency for Research on Cancer (IARC) in 2015.

According to the calculations made by the NGO Générations futures, the derogation concerns more than 8 700 tonnes of commercial products per year, just for France. Francois Veillerette, the spokesperson of the NGO, is indignant:

“It is aberrant in a regulation that wants to remove endocrine disruptors to protect the ecosystem.”

“This request doesn’t come from us but from the German authorities”, said Graeme Taylor, director of public affairs for the European Crop Protection Association (ECPA). The lobbying organization of the pesticide industry rejected the Commission’s proposal “as a whole”, considering that it “does not go far enough”.

Uncertain majority, proposal cut in half

Uncertain to get a majority on Wednesday, the European Commission cut off its contested proposal in two. The first scientific part contains an environmental component, including this new derogation, and a human health component, which is also the subject of strong criticism from the relevant scientific community, NGOs and certain Member States, including France.

They all denounced the inadequacy of the text to protect the population from diseases linked to exposure to endocrine disruptors (cancers, brain development problems, infertility, diabetes, etc.).

The second part of the proposal, on regulatory aspects, also contains a substantial derogation. If kept, the risks posed by endocrine disrupting pesticides would be assessed on a case-by-case basis after being placed on the market, whereas the law requires their a priori prohibition. This part is not only considered illegal by the European Parliament, NGOs and certain countries, but Le Monde revealed at the end of November, with supporting documents, that it was based on conclusions written in advance by an official European agency.

“These proposals are unacceptable and they do not respond to growing public concern or mobilization for genuine action that would reduce the presence of endocrine disruptors in our daily lives”,

said the coalition of NGOs EDC- Free Europe. An online petition from SumOfUs, calling to reject the proposal, has collected more than 260,000 signatures.

At the highest political level in Europe, where “good work” is considered to have been done, it is argued that there was a “scientific controversy” about endocrine disruptors to deal with. Yet a hundred respected scientists have warned decision-makers against a “manufacturing of doubt” financed by industries whose commercial interests are threatened, in the manner of the oil industry with climate change (Le Monde, November 30). Facts that a European official sweeps away, however, as “conspiracy theories”.

What happened on the 21.12.2016

MORE INFORMATION

The Investigation
    1. The Manufacture of a Lie.
    2. A Denial of the State of the Science.
    3. The Interference of the United States.
    4. The Discreet but Major Gift to the Pesticides Lobby.

 

Endocrine Disruptors

Endocrine disruptors: EFSA and ECHA outline Guidance plans

How to identify substances with endocrine disrupting properties in pesticides and biocides

EFSA and the European Chemicals Agency (ECHA) have published an outline of the Guidance they are developing on how to identify substances with endocrine disrupting properties in pesticides and biocides.

The outline includes a projected table of contents, as well as a plan of the drafting process, including timelines, responsibilities, consultations with relevant parties and an explanation of how the document will be endorsed.

The Guidance will enable applicants and regulatory authorities to identify endocrine disruptors among chemical substances proposed as pesticides and biocides using hazard-based scientific criteria currently being finalised by EU Member States and the European Commission.

The Guidance is to be drafted by a joint team of scientific staff from ECHA and EFSA, supported by the European Commission’s Joint Research Centre. Minutes of meetings of this drafting group will be published.

Endocrine disruptors: EFSA and ECHA outline Guidance plans, European Food Safety Authority, 20 December 2016.

Additional support to the group will be provided by a specially constituted Consultation Group, which will include members of ECHA’s Endocrine Disruptors Expert Group, and pesticide experts from EU Member States and other stakeholder groups. The drafting group may also consult other scientific bodies, such as EFSA’s Scientific Committee or its Panel on Plant Protection Products and their Residues (PPR) and this panel’s working groups.

A public consultation on the draft Guidance is scheduled for the summer of 2017.

More Information

  • Outline of draft Guidance for the implementation of hazard-based criteria to identify endocrine disruptors, efsa.europa.eu, 16 December 2016.
  • Request from the European Commission, ec.europa.eu, 17/10/2016
  • Minutes of joint EFSA/ECHA/JRC kick-off meeting on endocrine disruptors guidance, efsa.europa.eu.
  • European Commission’s proposed criteria for endocrine disruptors, ec.europa.eu.

Endocrine Disruptors: A Denial of the State of the Science

Part 2 of 3 – The European Commission relies on studies financed by industry

This article by Stéphane Horel was originally published by Le Monde on November 29. This version is translated by the Health and Environment Alliance and republished with permission on Environmental Health News first. This work is licensed under a Creative Commons Attribution-ShareAlike 4.0 International License. “Spray” Image Will Fuller.

“The current scientific knowledge:” It is this that the European Commission assures it is using to justify its much criticized choices in the regulation of endocrine disruptors. Yet, the Endocrine Society, a major scholarly society, believes that the Commission “ignores [the] state of science.” How can such a hiatus be explained?

To document its considerations, the Directorate-General for Health and Food Safety, responsible for the file at the Commission, carried out an impact assessment of more than 400 pages, which was published in June after having been under lock and key as a state secret. To what specific “scientific knowledge” does it refer?

The decision-making process began in 2009 and the “scientific knowledge” on endocrine disruptors has evolved considerably since then.

Above all, the Commission cites the opinion issued by one of its official agencies, the European Food Safety Authority, in 2013. This opinion is indeed the basis of its regulatory proposal. But the decision-making process began in 2009 and the “scientific knowledge” on endocrine disruptors has evolved considerably since then.

The Endocrine Society produced a review of the science in 2015. It examined 1,322 publications that had been published since its last review, which was actually in 2009. Conclusion? They do not leave “any doubt that EDCs [endocrine disruptors] are contributing to increased chronic disease burdens related to obesity, diabetes mellitus, reproduction, thyroid, cancers, and neuroendocrine and neurodevelopmental functions.”

In 2013, some 20 researchers working for nearly two years under the auspices of the World Health Organization (WHO) and the United Nations Environment Program (UNEP) had reached similar conclusions. Their report sounded the alarm bell on a “global threat that needs to be resolved.”

“Controversial interpretation”

These recent additions to “scientific knowledge” are indeed mentioned in the Commission’s impact assessment but disqualified on the basis that they do not deserve to be taken into consideration. “Evidence is scattered and its interpretation controversial,” the assessment report says, “so that a causal link or even a possible association between ED [endocrine disruptors] exposure at environmental levels and the diseases is not agreed among experts.”

In the wake of this damning reception, it reduces the Endocrine Society to a “stakeholder” who has issued a “statement.” As for the WHO/UNEP report, “scientific criticism to the general methodology used … was raised,” it indicates, citing a number of publications which it says show that the controversy “seems not resolved.” But what publications would be sufficiently authoritative as to be able to knock down the work carried out by the most respected specialists in the field?

Notably, the Commission’s negative comments are based on “critical comments,” published in 2014, challenging the methods and conclusions of the WHO/UNEP report. Among the ten authors of the comments, seven are working for two consulting companies, Exponent and Gradient Corp, which specialize in scientific issues and are known as “product-defense firms.”

But, most importantly, it was industry that sponsored the article through its lobbying organizations: the chemical sector with the European Chemical Industry Council (Cefic) and the American Chemistry Council and the pesticides sector with CropLife America, CropLife Canada, CropLife International and the European Crop Protection Association.

“Urban legend”

None of this can be unknown to the Commission services. Not only do these sponsors appear clearly in the declaration of interests at the end of the article, but industry itself sent it to them. Cefic sent it by e-mail to about 30 European officials involved in the case on March 17, 2014. In a message consulted by Le Monde, the industrialists explain that they have “commissioned a consortium of scientific experts to independently review the WHO-UNEP report,” fearing, in particular, that “despite its serious shortcomings it was being used to call for more precautionary chemicals policy.”

Other publications cited in the impact study include a two-page article, one of whose signatories is a person better known for his role as a consultant to the tobacco industry than for his competence on this topic. Among its co-authors are toxicologists paid by the chemical, pesticides and plastic industries.

Another article has again two consultants out of the three authors and talks about endocrine disruptors as an “urban legend” posing “imaginary health risks.” Making fun of the “hypothetical” effects of endocrine disruptors, such as the “reduced penis length and size,” they pose the question of “whether the whole issue of EDC is more within the competence of Dr. Sigmund Freud than that of toxicology.”

Can these texts really be incorporated into “scientific knowledge?” Why does the Commission give so much credit to documents that resemble lobbying material?

In a momentous editorial published today [November 29, 2016] in Le Monde, independent scientists express concerns about a “distortion of the evidence by industrially sponsored actors.” Signed by a hundred experts from two very different fields – endocrine disruption and climate change – their text notes the “dangerous consequences for the health of people and the environment” of this strategy of “manufacturing of doubt.”

MORE INFORMATION

The Investigation
    1. The Manufacture of a Lie.
    2. A Denial of the State of the Science.
    3. The Interference of the United States.
    4. The Discreet but Major Gift to the Pesticides Lobby.

 

Endocrine Disruptors

Endocrine Disruptors: The Manufacture of a Lie

Part 1 of 3 – The European Commission has developed its own evidence to avoid an overly stringent regulation of these hazardous substances

This article by Stéphane Horel was originally published by Le Monde on November 29. This version is translated by the Health and Environment Alliance and republished with permission on Environmental Health News first. This work is licensed under a Creative Commons Attribution-ShareAlike 4.0 International License. Image JULIE BALAGUE POUR LE MONDE.

Everything, or almost everything, is contained in a few words: “(Endocrine disruptors) can … be treated like most other substances of concern for human health and the environment.” It is on this simple phrase, which comes from the conclusion of an opinion from the European Food Safety Authority (EFSA) in 2013, that Brussels bases its plan to regulate endocrine disruptors, these ubiquitous substances capable of interfering with the hormonal system, often at low doses.

The proposal, which is due to be voted on by the Member States soon, has not only France, Denmark and Sweden united against it but also all the non-governmental organizations (NGOs) who consider that it does not protect public health and the environment.

The key phrase on which the regulatory edifice proposed by the Commission is built had been drafted even before any scientific expertise had really begun.

The expert scientific community, embodied by the Endocrine Society – a scholarly society that brings together some 18,000 researchers and clinicians specializing in the hormonal system – is also battling against the proposal. This opposition is surprising given that the European Commission insists that it relies on science, in the form of the scientific expertise of EFSA.

The explanation for this singular hiatus is found in a series of internal documents of the European administration obtained by Le Monde. They show, without ambiguity, that the key phrase on which the regulatory edifice proposed by the Commission is built had been drafted even before any scientific expertise had really begun.

Written conclusions in advance

In December 2012, EFSA was already presenting “conclusions/recommendations” in an e-mail to the experts it had assembled to carry out this work.

It said: “…endocrine disruptors and their adverse effects should be treated just like any other chemical of concern for human health or the environment.” The key phrase is already there. Yet, the very first meeting to set up work was held only a few days before. At the end of March 2013, three months later, the phrase figures in the conclusions of the opinion published by the agency.

“For sure, the conclusions were written beforehand, if not on paper, but in the heads of some of the participants,” a source close to the file at the time told Le Monde. The Commission itself did not respond to our questions. EFSA reacted with an assurance that it had properly fulfilled its mandate.

EFSA’s “Scientific Committee took stock of the various views from a number of experts and forums,” the European agency said when questioned.

The “EFSA phrase,” harmless for the uninitiated, has, in fact, a considerable weight. Because if endocrine disruptors were actually substances that are just like any others, then there would be no need for strict regulation.

The pesticide industry, which is most affected by the issue, has clearly understood the point. Its main lobbying organizations – the European Crop Protection Association (ECPA), CropLife International, CropLife America – or the German agrochemical groups BASF or Bayer, repeat ad libitum the “EFSA phrase” in arguments and correspondence with the European institutions that Le Monde has seen.

In fact, the famous phrase is of major importance for European regulation on plant protection products. It was in 2009 that the European Parliament voted a new “pesticides regulation.” According to this legislation, pesticides a priori identified as “endocrine disruptors” would no longer be allowed to enter or remain on the market except when the exposure is considered negligible.

This provision only needs one thing if it is to be applied: the adoption of scientific criteria to define endocrine disruptors – that is, what Brussels is proposing today. But since endocrine disruptors are chemical substances like any others – it’s the “EFSA phrase” that prompts the question: why prohibit them a priori?

“Major breach” in health protection

The Commission has therefore made an amendment to the text. Now, it is sufficient to assess the risk that they present on a case-by-case basis if problems arise after they have been placed on the market – and therefore a posteriori. Is this change at the cost of the spirit of the 2009 regulation?

This amendment would open a “major loophole” in the protection of health and the environment, says EDC-Free Europe. This coalition of NGOs accuses the Commission of wanting to distort the intention of European law.

But above all, this amendment to the 2009 regulation poses a democratic problem: it is much as if the officials have taken the initiative to draft an implementing decree that had nothing to do with the intention of the elected representatives.

The European Parliament is also of this opinion. In a copy of a letter seen by Le Monde and dated September 15, the chairman of the Parliament’s Environment Committee wrote to the Health Commissioner, Vytenis Andriukaitis, who is responsible for the file, saying that the project: “exceeds the implementing powers of the Commission” by amending “essential elements” of the law. Similarly, in their note of October 10, France, Denmark and Sweden do not say anything different, judging that the Commission has no right to change “a policy choice by the legislator.”

This rebuke is all the more unfortunate because it comes when the Commission is already in a state of illegality on this issue. The European Court of Justice actually condemned the Commission in December 2015 for violating EU law: the Commission had been required to settle the question of the criteria to identify endocrine disrupters before the end of 2013.

However, the Commission remains unfazed by the shower of criticism. It offers an assurance that it has fulfilled the condition which authorizes it to “update” the regulation: to take into account the evolution of “scientific knowledge,” namely the famous little phrase of EFSA. It is that phrase on which its justification rests.

But why should EFSA have written, in advance, a conclusion in breach of the scientific consensus? An internal Commission document obtained by Le Monde sheds some light on the intentions of the Directorate General for Health and Food Safety (DG Health), which is now responsible for the matter at the Commission.

“What we see here is policy-based evidence-making.”

Axel Singhofen, Greens-European Free Alliance.

A meeting report records in black and white that, as of September 2012, DG Health intends to disregard the will of elected representatives in Europe. The health directorate said then that it “did not oppose even the idea to go back to regulating based on risk assessment” and was “ready to change entirely” the part of the regulation concerned.

The same document states further on that DG Health will have to “talk with EFSA to try and accelerate the preparation” of its opinion. At this point, EFSA’s opinion did not exist … The agency had only just been asked to set up a working group on endocrine disruptors.

A “mortified” message

The very special conditions in which this working group operated can be read in e-mails exchanged by EFSA experts and officials. One month before the release of the EFSA report, the World Health Organization (WHO) and the United Nations Environment Program (UNEP) published a joint report on endocrine disruptors.

A mortified EFSA expert sent a message to the whole group: “It is almost embarrassing to compare the current draft report with the WHO-UNEP report … when WHO-UNEP comes to the conclusion that traditional risk assessment of chemicals is not fit for purpose to assess (endocrine disruptors), we are exactly coming to the opposite conclusion.”

This scientist considered it essential that the conclusions be radically changed. The EFSA official overseeing the work of the expert group agreed.

The “current conclusions where we explain that [endocrine disruptors] should be considered like most other chemicals […] puts us in isolation compared to the rest of the world, and may be hard to defend,” he writes. However, when EFSA’s opinion is published on March 20, 2013, it continued to include, unperturbed, the little phrase.

“This should be a science-based procedure … evidence-based policy-making,” says Axel Singhofen, an adviser to the Greens-European Free Alliance in the European Parliament. “But what we see here is policy-based evidence-making.”

MORE INFORMATION

The Investigation
    1. The Manufacture of a Lie.
    2. A Denial of the State of the Science.
    3. The Interference of the United States.
    4. The Discreet but Major Gift to the Pesticides Lobby.

 

Endocrine Disruptors

Glyphosate carcinogenic evaluation: different views between the IARC and the EFSA

Glyphosate: scientists publish a paper summarising flaws of EFSA review compared to IARC’s

image of glyphosate-spraying
Serious flaws in the European Food Safety Authority (EFSA) scientific evaluation in the Renewal Assessment Report for glyphosate (RAR) incorrectly characterise the potential for a carcinogenic hazard from exposure to glyphosate – as unlikely… Since the RAR is the basis for the European Food Safety Agency (EFSA) conclusion it is critical that these shortcomings are corrected.

Summary

Differences in the carcinogenic evaluation of glyphosate between the International Agency for Research on Cancer (IARC) and the European Food Safety Authority (EFSA), J Epidemiol Community Health doi:10.1136/jech-2015-207005, March 2016.

The International Agency for Research on Cancer (IARC) working groups (WG) concluded that glyphosate is a ‘probable human carcinogen’, putting it into IARC category 2A due to sufficient evidence of carcinogenicity in animals, limited evidence of carcinogenicity in humans and strong evidence for two carcinogenic mechanisms.

  • The IARC WG found an association between non-Hodgkin lymphoma (NHL) and glyphosate based on the available human evidence.
  • The IARC WG found significant carcinogenic effects in laboratory animals for rare kidney tumours and hemangiosarcoma in two mouse studies and benign tumours in two rat studies.
  • The IARC WG concluded that there was strong evidence of genotoxicity and oxidative stress for glyphosate, entirely from publicly available research, including findings of DNA damage in the peripheral blood of exposed humans.

The Renewal Assessment Report (RAR) by the European Food Safety Authority (EFSA) concluded (Vol. 1, p.160) that ‘classification and labelling for carcinogenesis is not warranted’ and ‘glyphosate is devoid of genotoxic potential’.

  • EFSA classified the human evidence as ‘very limited’ and then dismissed any association of glyphosate with cancer without clear explanation or justification.
  • Ignoring established guidelines cited in their report, EFSA dismissed evidence of renal tumours in three mouse studies, hemangiosarcoma in two mouse studies and malignant lymphoma in two mouse studies. Thus, EFSA incorrectly discarded all findings of glyphosate-induced cancer in animals as chance occurrences.
  • EFSA ignored important laboratory and human mechanistic evidence of genotoxicity.
  • EFSA confirmed that glyphosate induces oxidative stress but then, having dismissed all other findings of possible carcinogenicity, dismissed this finding on the grounds that oxidative stress alone is not sufficient for carcinogen labelling.

The most appropriate and scientifically based evaluation of the cancers reported in humans and laboratory animals as well as supportive mechanistic data is that glyphosate is a probable human carcinogen. On the basis of this conclusion and in the absence of evidence to the contrary, it is reasonable to conclude that glyphosate formulations should also be considered likely human carcinogens. The classification, labelling and packaging (CLP) criteria (Table 3.6.1, p.371) allow for a similar classification of Category 1B when there are ‘studies showing limited evidence of carcinogenicity in humans together with limited evidence of carcinogenicity in experimental animals’.

In the RAR, almost no weight is given to studies from the published literature and there is an over-reliance on non-publicly available industry-provided studies using a limited set of assays that define the minimum data necessary for the marketing of a pesticide. The IARC WG evaluation of probably carcinogenic to humans accurately reflects the results of published scientific literature on glyphosate and, on the face of it, unpublished studies to which EFSA refers.

Most of the authors of this commentary previously expressed their concerns to EFSA and others regarding their review of glyphosate to which EFSA has published a reply. This commentary responds to the EFSA reply.

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